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Labelling Strategy Associate Director
Location:
Boston, MA
Description:
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.We are hiring a Labelling Strategy Associate Director that will provide regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT). This individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products. The individual contributes to the Development of the labelling group by sharing knowledge and mentoring peers. Locations: Boston, MA What You'll DoEnsures that the labelling process is followed through the lifecycle of the product.Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.Leads the PLT in the preparation and maintenance of high quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.Leads the development of labelling negotiation strategies, anticipating HA perspectives.Provides labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigationsEvaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labellingEnsures appropriate communication across Labelling sub-functionsAble to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.Leads the development of target labelling documents as appropriateAssist in the development of labelling policies, procedures and SOPsEssential for the RoleUniversity Degree in Science or related discipline3+ years' pharmaceutical experience, with at least 1 year of regulatory experience.Knowledge of labelling regulations and guidanceExcellent verbal and written communication skillsKeen attention to detail and accuracyMulti-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.Ability to assimilate clinical and scientific information and present it in a concise mannerAbility to think strategically, appropriately assess risks and formulate strategies to manage riskMust demonstrate competencies in:Building Relationships (works well across formal and informal networks)Negotiation Skills (good listener; able to build a consensus)Critical Information Seeking (works well across formal and informal networks)Rational Persuasion (able to distil an issue to its key components and suggest solutions)Interpersonal Awareness (aware of how actions affect other people)Desirable for the RoleExperience in Labelling development and/or maintenanceKnowledge of major markets Labelling regulationsAdvanced academic training is highly desirable (PharmD, PhD) Date Posted 15-May-2024 Closing Date 14-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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More About this Listing: Labelling Strategy Associate Director
Labelling Strategy Associate Director is a Executive Associate Director Job at Astrazeneca located in Boston MA. Find other listings like Labelling Strategy Associate Director by searching Oodle for Executive Associate Director Jobs.
Labelling Strategy Associate Director is a Executive Associate Director Job at Astrazeneca located in Boston MA. Find other listings like Labelling Strategy Associate Director by searching Oodle for Executive Associate Director Jobs.